AsthmaPhase 1NCT03942666
PK Linearity and Steady State PK of CHF 6532 in Healthy Subjects
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
Trial summary
The purpose of this clinical pharmacology study is to evaluate the CHF 6532 linearity after single oral administrations of four doses of a tablet formulation and to evaluate the pharmacokinetic (PK) at steady state following the repeated open label b.i.d. administration at one dose. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Treatment A, Treatment B and Treatment C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 10 May 2019to 22 Nov 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject's written informed consent obtained prior to any study-related procedure;
- Healthy male or female subjects aged 18-60 years inclusive;
- Ability to understand the study procedures, the risks involved and willingness to follow the study procedures including intake of non-permitted concomitant medications;
- Body Mass Index (BMI) between 19.0 and 30.0 kg/m2 extremes inclusive;
- Non- or ex-smokers who smoked < 5 pack years;
- Good physical and mental status, determined on the basis of the medical history and a general physical examination;
Show all 10Show fewer
- Vital signs within normal limits;
- Body temperature 35.5-37.2ºC;
- 12-lead digitised Electrocardiogram (12-lead ECG) considered as normal;
- Female subject of non-childbearing potential (WONCBP) defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile) and female subjects of childbearing potential (WOCBP) fulfilling one of the following criteria: a/ WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up visit or b/WOCBP with non-fertile male partners: (contraception is not required in this case).
Who cannot join
- Clinically significant abnormal 24 hours Holter ECG at screening;
- Subjects with history of sustained and non-sustained cardiac arrhythmias (ECG demonstrated) and subjects with a family history of sudden cardiac death;
- Blood donation or blood loss (equal or more than 450 ml) less than 8 weeks prior to randomisation;
- Abnormal haemoglobin level;
- Subjects with history of asthma, including childhood asthma, COPD or any other chronic pulmonary diseases or condition;
- Positive HIV1 or HIV2 serology;
Show all 22Show fewer
- Positive results for the Hepatitis serology;
- Clinically relevant and uncontrolled hepatic, gastrointestinal, endocrine, metabolic (specially, subjects with deficiency in glucuronidation), neurologic, or psychiatric disorder that may interfere with successful completion of this protocol according to the Investigator's judgement;
- Any clinically relevant abnormal laboratory value suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the subject or the evaluation of the result of the study according to the Investigator's judgment;
- Abnormal liver enzymes;
- Unsuitable veins for repeated venepuncture;
- History of substance abuse or drug abuse within 12 months prior to screening;
- Subjects who have received an investigational drug or device within 1 month or 7 times the elimination half-life (whichever is longer) prior to screening visit or are currently participating in another clinical trial or have been previously randomised in this trial;
- History of hypersensitivity to any of the excipients contained in the formulation used in the trial;
- Known intolerance/hypersensitivity to quinolone-type antibiotics, e.g. moxifloxacin, norfloxacin, ciprofloxacin, nalidixic acid;
- Heavy caffeine drinker;
- Subjects who have a positive urine test;
- Subject taking any drug treatment, including prescribed or OTC medicines as well as vitamins, homeopathic remedies etc, in the 14 days before the screening until randomisation, with the exception of: Occasional paracetamol, Hormonal contraceptives, Hormonal replacement treatment for post-menopausal women;
- Subject taking enzyme-inducing drugs, enzyme-inhibiting drugs, biologic drugs or any drug known to have a well-defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole) in the 3 months before screening until randomisation;
- Pregnant or lactating women;
- History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina or symptomatic arrhythmias. Subjects will also be excluded if there is a family history of long QT syndrome or Brugada syndrome or unexplained sudden death;
- Use of medications which are known to carry a risk of prolong the QTc interval is not allowed within 14 days or 7 times the elimination half-life (whichever is longer) before the baseline ECG.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
SGS Life Sciences - Clinical Pharmacology Unit Antwerpen
Antwerp, 2060
About this study
Official title: A Clinical Pharmacology Study to Evaluate the CHF 6532 Linearity After Single Oral Administrations of Four Doses of a Tablet Formulation Followed by an Evaluation of the Pharmacokinetic at Steady State Following the Repeated Open Label b.i.d. Administration at One Dose
The purpose of this clinical pharmacology study is to evaluate the CHF 6532 linearity after single oral administrations of four doses of a tablet formulation and to evaluate the pharmacokinetic (PK) at steady state following the repeated open label b.i.d. administration at one dose.
Read the detailed description
The study consists in two parts. The first study part (Part I) is a single dose, randomised, double-blind, placebo-controlled, 5-way, 5-period crossover design, in healthy subjects.
The second study part (Part II) is a repeated dose, open label treatment in healthy subjects.
The PK of CHF 6532 and CHF 6532 acyl glucuronide metabolite (CHF 6532-AG), the cardiac safety will be assessed after single or repeated administration of CHF 6532 tablet formulations in healthy subjects under fed conditions.
A total of 30 healthy male and female are planned to be included where they will participate the 2 study parts.
Standard safety assessments will be conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs and observations of any adverse events. Blood and urines samples will be also collected for PK analysis. Holter recordings will be performed to build a prospective concentration-response model of QTc for CHF 6532 in Part I and for cardiac safety purpose at steady state in Part II.
- Conditions
- Asthma
- Being tested
- Treatment A, Treatment B, Treatment C, Treatment D, Treatment E
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment ADrug
tablet of CHF 6532
Treatment BDrug
tablet of CHF 6532
Treatment CDrug
tablet of CHF 6532
Treatment DDrug
tablet of CHF 6532
Treatment EDrug
Placebo tablet of CHF 6532
Treatment FDrug
tablet of CHF 6532
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Single administration of CHF 6532 Dose #1 Receives: Drug: Treatment A |
| Treatment B | Experimental | Single administration of CHF 6532 Dose #2 Receives: Drug: Treatment B |
| Treatment C | Experimental | Single administration of CHF 6532 Dose #3 Receives: Drug: Treatment C |
| Treatment D | Experimental | Single administration of CHF 6532 Dose #4 Receives: Drug: Treatment D |
| Treatment E | Placebo comparator | Single administration of CHF 6532 Placebo Receives: Drug: Treatment E |
| Treatment F | Other | Part II: Administration of tablet of CHF 6532 b.i.d. for 10 days at one dose. Receives: Drug: Treatment F |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK linearity of CHF 6532
Assessment of CHF 6532 PK linearity in blood and urine depending on increasing doses of CHF 6532
Measured: Over 12 hours after administration in urine, over 48 hours after administration in blood
Steady state PK of CHF 6532
Assessment of CHF 6532 PK in blood and urine after a repeated administration of CHF 6532
Measured: Over 12 hours after administration at Day 1 and Day 10 in urine, over 12 hours after administration at Day 1 and over 24 hours after administration at Day 10 in blood
Secondary outcomes (3)
Cardiac Safety of CHF 6532
Holter recording
Measured: Over 24 hours after single administration in Part I, Over 24 hours at Day 10 in Part II
PK linearity of CHF 6532-AG
Assessment of CHF 6532-AG PK in blood and urine depending on increasing doses of CHF 6532
Measured: Over 12 hours after administration in urine, over 48 hours after administration in blood
Steady state PK of CHF 6532-AG
Assessment of CHF 6532-AG PK in blood and urine after a repeated administration of CHF 6532
Measured: Over 12 hours after administration at Day 1 and Day 10 in urine, over 12 hours after administration at Day 1 and over 24 hours after administration at Day 10 in blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start10 May 2019
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Part I: 5-way, 5-period crossover Part II: single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942666
- Sponsor's protocol ID
- CLI-06532AA1-03
- Other IDs
- 2019-000250-59, 2019
- Status last verified
- Jul 2020
- First submitted
- 6 May 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacology Study to Evaluate the CHF 6532 Linearity After Single Oral Administrations of Four Doses of a Tablet Formulation Followed by an Evaluation of the Pharmacokinetic at Steady State Following the Repeated Open Label b.i.d. Administration at One Dose
- ClinicalTrials.gov ID
- NCT03942666
- Acronym / sponsor ID
- CLI-06532AA1-03
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 10 May 2019 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical pharmacology study is to evaluate the CHF 6532 linearity after single oral administrations of four doses of a tablet formulation and to evaluate the pharmacokinetic (PK) at steady state following the repeated open label b.i.d. administration at one dose.
Detailed description
The study consists in two parts. The first study part (Part I) is a single dose, randomised, double-blind, placebo-controlled, 5-way, 5-period crossover design, in healthy subjects.
The second study part (Part II) is a repeated dose, open label treatment in healthy subjects.
The PK of CHF 6532 and CHF 6532 acyl glucuronide metabolite (CHF 6532-AG), the cardiac safety will be assessed after single or repeated administration of CHF 6532 tablet formulations in healthy subjects under fed conditions.
A total of 30 healthy male and female are planned to be included where they will participate the 2 study parts.
Standard safety assessments will be conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs and observations of any adverse events. Blood and urines samples will be also collected for PK analysis. Holter recordings will be performed to build a prospective concentration-response model of QTc for CHF 6532 in Part I and for cardiac safety purpose at steady state in Part II.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Part I: 5-way, 5-period crossover Part II: single group
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Treatment ASingle administration of CHF 6532 Dose #1 |
| Treatment B | Experimental | Drug: Treatment BSingle administration of CHF 6532 Dose #2 |
| Treatment C | Experimental | Drug: Treatment CSingle administration of CHF 6532 Dose #3 |
| Treatment D | Experimental | Drug: Treatment DSingle administration of CHF 6532 Dose #4 |
| Treatment E | Placebo comparator | Drug: Treatment ESingle administration of CHF 6532 Placebo |
| Treatment F | Other | Drug: Treatment FPart II: Administration of tablet of CHF 6532 b.i.d. for 10 days at one dose. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject's written informed consent obtained prior to any study-related procedure;
- Healthy male or female subjects aged 18-60 years inclusive;
- Ability to understand the study procedures, the risks involved and willingness to follow the study procedures including intake of non-permitted concomitant medications;
- Body Mass Index (BMI) between 19.0 and 30.0 kg/m2 extremes inclusive;
- Non- or ex-smokers who smoked < 5 pack years;
Key exclusion criteria (22 listed)
- Clinically significant abnormal 24 hours Holter ECG at screening;
- Subjects with history of sustained and non-sustained cardiac arrhythmias (ECG demonstrated) and subjects with a family history of sudden cardiac death;
- Blood donation or blood loss (equal or more than 450 ml) less than 8 weeks prior to randomisation;
- Abnormal haemoglobin level;
- Subjects with history of asthma, including childhood asthma, COPD or any other chronic pulmonary diseases or condition;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment Atablet of CHF 6532 | Drug | Treatment A |
| Treatment Btablet of CHF 6532 | Drug | Treatment B |
| Treatment Ctablet of CHF 6532 | Drug | Treatment C |
| Treatment Dtablet of CHF 6532 | Drug | Treatment D |
| Treatment EPlacebo tablet of CHF 6532 | Drug | Treatment E |
| Treatment Ftablet of CHF 6532 | Drug | Treatment F |
Primary outcome
PK linearity of CHF 6532
Time frame: Over 12 hours after administration in urine, over 48 hours after administration in blood
Assessment of CHF 6532 PK linearity in blood and urine depending on increasing doses of CHF 6532
Steady state PK of CHF 6532
Time frame: Over 12 hours after administration at Day 1 and Day 10 in urine, over 12 hours after administration at Day 1 and over 24 hours after administration at Day 10 in blood
Assessment of CHF 6532 PK in blood and urine after a repeated administration of CHF 6532
3 secondary outcomes
Cardiac Safety of CHF 6532
Time frame: Over 24 hours after single administration in Part I, Over 24 hours at Day 10 in Part II
PK linearity of CHF 6532-AG
Time frame: Over 12 hours after administration in urine, over 48 hours after administration in blood
Steady state PK of CHF 6532-AG
Time frame: Over 12 hours after administration at Day 1 and Day 10 in urine, over 12 hours after administration at Day 1 and over 24 hours after administration at Day 10 in blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK linearity of CHF 6532 (time frame: Over 12 hours after administration in urine, over 48 hours after administration in blood). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.